The aging of the population and the epidemic of obesity have led to a rapid increase in the number of older, obese individuals with diabetes. Little is known about the long-term health effects of lifestyle intervention designed to lower weight and increase physical activity in this population. This application, which responds to RFA-DK-12-502, is submitted by one of the 16 clinical centers in the Action for Health in Diabetes (Look AHEAD) Consortium. All 16 clinical sites and the Coordinating Center have submitted parallel applications. This application proposes to continue the Look AHEAD clinical trial as an observational cohort study and to follow participants with new assessments of the health problems of greatest concern in older, obese individuals with type 2 diabetes. We will test whether random assignment to 9-11 years of intensive lifestyle intervention, compared to a control condition of diabetes support and education, results in improvements in 1) physical function, impairment and disability, 2) cognitive function and impairment, 3) diabetes control and micro vascular complications, 4) late life depression, and 5) fractures and cancers. Secondary aims are to examine whether subgroup differences observed during the trial (which raised concern about possible unfavorable effects of intensive lifestyle intervention in those with a prio history of cardiovascular disease) endure and whether the excellent weight losses achieved in the intensive lifestyle intervention arm are maintained despite the absence of continued intervention activities. The Continuation will also support ongoing ancillary studies, maintain infrastructure for new ancillary studies, and sustain thorough analyses and publication of the data collected by Look AHEAD. We will continue to follow the Look AHEAD cohort (approximately 4,000 participants) across the 16 clinical sites. Participants entered the trial 9-1 years ago when they were obese or overweight and aged 45- 76, and were randomly assigned with equal probability to either an intensive lifestyle intervention that has induced sustained weight loss and increased physical activity or control condition (diabetes support and education). Both arms have had excellent retention. Interventions were discontinued in Sept, 2012, but follow- up of the cohort continues. This application will fund one additional clinic visi and ongoing telephone-based outcome assessment. This application builds on the remarkable success of the Look AHEAD in inducing and sustaining weight loss and retaining participants. The planned continuation addresses important public health priorities for a rapidly growing and under-studied segment of the US population in a cost-effective manner, leveraging the extensive resources available from Look AHEAD.

Public Health Relevance

The number of older, obese individuals with type 2 diabetes is rapidly increasing and little is known about the impact of lifestyle interventions during midlife o the long-term health of this population. This application seeks to continue to follow the Action fo Health in Diabetes (Look AHEAD) cohort as an observational study, and to compare individuals who were randomly assigned to intensive lifestyle intervention with those assigned to the control condition on new measures of the health problems of greatest concern in this population, such as cognitive and physical function, micro vascular complications, and late-life depression.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
2U01DK057135-15
Application #
8600070
Study Section
Special Emphasis Panel (ZDK1-GRB-S (M2))
Program Officer
Evans, Mary
Project Start
1999-09-30
Project End
2015-07-31
Budget Start
2013-09-01
Budget End
2014-07-31
Support Year
15
Fiscal Year
2013
Total Cost
$946,794
Indirect Cost
$355,048
Name
University of Pennsylvania
Department
Psychiatry
Type
Schools of Medicine
DUNS #
042250712
City
Philadelphia
State
PA
Country
United States
Zip Code
19104
Espeland, Mark A; Carmichael, Owen; Hayden, Kathleen et al. (2018) Long-term Impact of Weight Loss Intervention on Changes in Cognitive Function: Exploratory Analyses from the Action for Health in Diabetes Randomized Controlled Clinical Trial. J Gerontol A Biol Sci Med Sci 73:484-491
Hayden, Kathleen M; Baker, Laura D; Bray, George et al. (2018) Long-term impact of intensive lifestyle intervention on cognitive function assessed with the National Institutes of Health Toolbox: The Look AHEAD study. Alzheimers Dement (Amst) 10:41-48
Houston, Denise K; Neiberg, Rebecca H; Miller, Michael E et al. (2018) Physical Function Following a Long-Term Lifestyle Intervention Among Middle Aged and Older Adults With Type 2 Diabetes: The Look AHEAD Study. J Gerontol A Biol Sci Med Sci 73:1552-1559
Brinkley, Tina E; Anderson, Andrea; Soliman, Elsayed Z et al. (2018) Long-Term Effects of an Intensive Lifestyle Intervention on Electrocardiographic Criteria for Left Ventricular Hypertrophy: The Look AHEAD Trial. Am J Hypertens 31:541-548
Unick, Jessica L; Gaussoin, Sarah A; Hill, James O et al. (2017) Objectively Assessed Physical Activity and Weight Loss Maintenance among Individuals Enrolled in a Lifestyle Intervention. Obesity (Silver Spring) 25:1903-1909
Look AHEAD Research Group (2017) Effects of a long-term lifestyle modification programme on peripheral neuropathy in overweight or obese adults with type 2 diabetes: the Look AHEAD study. Diabetologia 60:980-988
Sanguankeo, Anawin; Lazo, Mariana; Upala, Sikarin et al. (2017) Effects of visceral adipose tissue reduction on CVD risk factors independent of weight loss: The Look AHEAD study. Endocr Res 42:86-95
Rushing, J; Wing, R; Wadden, T A et al. (2017) Cost of intervention delivery in a lifestyle weight loss trial in type 2 diabetes: results from the Look AHEAD clinical trial. Obes Sci Pract 3:15-24
Shechter, Ari; Foster, Gary D; Lang, Wei et al. (2017) Effects of a lifestyle intervention on REM sleep-related OSA severity in obese individuals with type 2 diabetes. J Sleep Res 26:747-755
Johnson, Karen C; Bray, George A; Cheskin, Lawrence J et al. (2017) The Effect of Intentional Weight Loss on Fracture Risk in Persons With Diabetes: Results From the Look AHEAD Randomized Clinical Trial. J Bone Miner Res 32:2278-2287

Showing the most recent 10 out of 111 publications